New law requires prescribers to "Start Talking," use consent form
11/21/14 Update: For the purpose of the Start Talking! form, the Ohio State Dental Board is moving forward with a rule change to define surgery as “any procedure that involves cutting or otherwise infiltrating hard or soft human tissue; including but not limited to, gingical, bone and tooth structure, by mechanical means, including, laser surgery, therapeutic ionizing radiation, therapeutic ultrasound.” For more information, continue reading below.
This summer Gov. John Kasich signed House Bill 314 into law. The law requires prescribers to obtain a statutorily defined informed consent form, known as the “Start Talking!” form from a parent, guardian or other authorized adult prior to prescribing a minor a controlled substance that contains an opioid. A minor is defined as a person under the age of 18 who is not emancipated. Once completed, this form must be kept as a permanent part of the medical or dental record. The provisions of the new law went into effect Sept. 17.
In addition to obtaining a completed consent form, prescribers are required to assess whether the patient “has ever suffered, or is currently suffering, from mental health or substance abuse disorders,” and if the patient has or is currently taking prescription drugs for treatment of those disorders. Also, the prescriber must discuss with the patient and the responsible adult all of the following:
- the risk of addiction and overdose associated with the drug,
- the increased risk of addiction to controlled substances by individuals suffering from both mental and substance abuse disorders,
- the dangers of taking controlled substances containing opioids with benzodiazepines, alcohol, or other depressants, and
- any information contained in the patient counseling information section of the labeling for the drug.
Upon completing the conversation, prescribers must obtain written consent for the prescription on the Start Talking! form from a parent, guardian or another adult authorized to consent for medical treatment, defined as someone whom a parent or guardian has given written authorization to consent for treatment.
A Start Talking! form was developed by the Ohio Medical Board and distributed to interested parties on Aug. 25. The form can be downloaded by clicking here. Under the law, this form must contain: the name and quantity of the drug being prescribed, the amount of the initial dose, a statement indicating that a controlled substance is a drug that the government has identified as having a potential for abuse, a statement certifying that the prescriber discussed the items previously mentioned above, and the number of refills, if any.
The new law does establish several exceptions to the Start Talking! requirements for prescribers. However, it is unclear whether these exceptions would apply in dental offices.
First, the requirements may be waived if the prescriber believes “fulfilling the requirements … would be a detriment to the minor’s health or safety.” A second exception exists in those instances where treatment is “rendered in a hospital, ambulatory surgical facility, nursing home, pediatric respite care program, residential care facility, freestanding rehabilitation facility, or similar institutional facility.” Prescribers’ offices in or adjacent to one of these facilities are not included in the excepted locations.
Third, the requirements do not apply in a medical emergency, defined as a situation that creates an “immediate threat of serious risk to the life or physical health” of the minor patient. An argument could be made that this situation may arise in a dental office. However, regulators may consider the vast majority of dental situations to not fit within the emergency definition.
A final exception to the law is in those situations where the treatment is incident to a surgery performed in either an inpatient or outpatient setting. As noted in the updated, the Ohio State Dental Board is working to define surgery as “any procedure that involves cutting or otherwise infiltrating hard or soft human tissue; including but not limited to, gingical, bone and tooth structure, by mechanical means, including, laser surgery, therapeutic ionizing radiation, therapeutic ultrasound.”
The Ohio State Dental Board is charged with enforcing these new requirements in dental offices. Initial versions of the bill creating the law called for a mandatory six month license suspension and a civil penalty of up to $20,000 for any violation. The Ohio Dental Association successfully advocated for removal of these penalties and to allow the dental board to enforce the law based upon its expertise in dentistry.
For more information on the Start Talking! requirements and other prescription drug regulations, please contact the ODA legal department at (800) 282-1526.